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510(k) K200615

Signature ONE System by Orthosoft Inc (D/B/A Zimmer Cas) — Product Code QHE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2020
Date Received
March 9, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shoulder Arthroplasty Implantation System
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

Other clearances by Orthosoft Inc (D/B/A Zimmer Cas)

  • K233199 — ROSA® Shoulder System (February 21, 2024)
  • K230567 — OptiVu™ ROSA® MxR (June 13, 2023)
  • K231162 — ROSA Hip System (May 23, 2023)
  • K230180 — Rosa Knee System (February 22, 2023)
  • K220733 — OptiVu ROSA MxR (July 29, 2022)
  • K213708 — ROSA® Knee System (April 22, 2022)
  • K212560 — Signature™ ONE System (October 12, 2021)
  • K192080 — iASSIST Knee System (November 5, 2019)
  • K192074 — Signature ONE System (August 30, 2019)
  • K183544 — Efficient Care 3D Planning (August 23, 2019)

Other clearances for product code QHE

  • K260104 — Signature™ ONE System (February 4, 2026)
  • K251558 — Precision AI Surgical Planning System (PAI-SPS) (January 12, 2026)
  • K243509 — Archer PSI System (May 12, 2025)
  • K241470 — CORE Shoulder System (February 20, 2025)
  • K243955 — Precision AI Surgical Planning System (PAI-SPS) (January 21, 2025)
  • K242813 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase S (October 18, 2024)
  • K241097 — Arthrex Virtual Implant Positioning (VIP) System Software (October 2, 2024)
  • K233992 — Precision AI Surgical Planning System (PAI-SPS) (August 5, 2024)
  • K241143 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase S (May 22, 2024)
  • K232425 — Signature™ ONE System (December 12, 2023)